Sr Packaging Engineer
ATR International - Boulder, CO
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We are seeking a Sr Packaging Engineer for a very important client.The packaging engineer is part of a dynamic team that provides expertise in packaging engineering and ensures quality and regulatory compliance. Supports and/or leads projects and collaborates with stakeholders to achieve desired results. Responsibilities include the following:- Evaluate the current state of various medical device product packaging design; perform gap analysis on existing studies to the latest industry standards such as ISO11607 Part 1 and 2.- Generate and execute packaging remediation plans for sterile barrier systems and non-sterile medical device packaging. Define remediation plans, generate/execute protocols, author closing reports, update specifications and technical documentation.- Leads successful validation of packaging systems for medical devices- Identify and develop innovative packaging processes and designs as part of a cross functional team. Determines packaging specifications according to the nature of the product, cost limitations, legal requirements, and the type of device protection required.- Utilize quality and regulatory compliance knowledge to support regulatory body audits, draft technical responses and provide innovative ideas to ensure compliance to latest industry practices.- Lead project meetings and provide updates to management.- Assist in labeling development process.- May perform and evaluate testing in a laboratory environment as per industry standards. Requirement: The ideal candidate will possess the following qualifications:Minimum Requirements- Bachelor of Science Degree in Packaging Science, Mechanical Engineering or similar discipline.- Minimum of 5 years in medical device or pharmaceutical industry in Packaging or Quality Engineering.- Requires practical knowledge and demonstrated competence within packaging engineering typically obtained through advanced education combined with experience.- Knowledge and general understanding of ISO 11607 part 1 and 2, ASTM and ISTA package test methods is required.- Established and productive individual contributor with strong team and interpersonal skills.- Knowledge of Microsoft Office programs is required.- CAD/CAPE/TOPS Software knowledge is preferred.Top 3 things you are looking for in a candidates experience:1. Packaging Gap assessments and remediation for medical devices. Perform gap analysis on existing studies to the latest industry standards such as ISO11607 Part 1 and 22. Generate and execute packaging remediation plans (including package development) for sterile barrier systems and non-sterile medical device packaging.3. Lead project meetings and provide updates to managementEducation Required: Bachelor of Science Degree in Packaging Science, Mechanical Engineering or similar disciplineYears? Experience Required: Minimum of 5 years in medical device or pharmaceutical industry in Packaging
Created: 2024-09-07